[ExI] Coalition Wants Moratorium on 'Extreme' Synthetic Bio Businesses

[James Clement]

Arggg!

Coalition Wants Moratorium on 'Extreme' Synthetic Bio Businesses
March 13, 2012

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 By Matt Jones

NEW YORK (GenomeWeb News) – An international advocacy coalition today
called for a moratorium on the development of new synthetic organisms for
commercial use while new international regulations for governing the
synthetic biology sector are created to protect the environment and people
from unknown perils.

The coalition said today that synbio represents "extreme genetic
engineering." It said there currently is little or no governance over
synthetic organisms, and private companies cannot be trusted to
self-regulate and protect people and the environment from risk and harm.

"We are calling for a global moratorium on the release and commercial use
of synthetic organisms until we have established a public interest research
agenda, examined alternatives, developed the proper regulations, and put
into place rigorous biosafety measures," Carolyn Raffensperger, executive
director of the Science and Environmental Health Network, said in a
statement today.

"Self-regulation of the synthetic biology industry simply won't work,"
added Andy Kimbrell, executive director of the International Center for
Technology Assessment. "Current laws and regulations around biotechnology
are outdated and inadequate to deal with the novel risks posed by synthetic
biology technologies and their products."

Friends of the Earth and over 100 international groups focused on
environmental, bioscience, food safety, human and consumer rights issues,
and religion, said in areport published
today<http://www.genomeweb.com/www.foe.org/principles-for-synthetic-biology>
that
although the synbio market had a value of more than $1.6 billion in 2011
and could hit $10.8 billion by 2016, there has been "little or no
governance of the industry or assessment of the novel risks posed by
synthetic organisms."

In a conference call today unveiling the report, Jaydee Hanson, policy
director at the International Center for Technology Assessment, said that
the first creation of a synthetic
genome<http://www.genomeweb.com/jcvi-team-creates-functional-microbe-controlled-synthetic-genome>
and
its implantation into a microbe by the J. Craig Venter Institute in 2010
"should have been a wake-up call for governments around the world, but
little new oversight resulted."

"The ability to synthesize DNA and create synthetic organisms and products
is far outpacing our understanding of how these novel products work in the
real world. Even engineering simple organisms could have major ecological
and health effects," Hanson said.

In its report, "The Principles for the Oversight of Synthetic Biology," the
consortium calls for governments to take specific steps to account for a
range of possible effects caused by synthetic organisms.

It calls for a moratorium on the release and commercial use of synthetic
organisms, cells, or genomes, until a government research agenda has been
established to study the public's interest. The moratorium also would hold
while alternative approaches are considered and risk assessments are made,
and international oversight and security mechanisms are developed.

The group also wants mandatory regulations that would treat synthetic
biology as a unique activity and would be stronger than current the
regulations on pathogens, containment, drugs, and worker protections.

The report seeks a number of public health and worker safety regulations
for preventing human exposures to synthetic organisms that have not been
proven safe. These would include protocols to ensure that the organisms are
securely contained, that the public would be informed of the nature of the
work being conducted in the community, and that workers and the public be
informed of risks associated with synthetic biology and organisms. Another
requirement suggested by the group is that methods be available for
tracking, disabling, or destroying synbio strains, if necessary.

Requirements also need to be put in place to protect against the potential
dangers that synthetic organisms might pose if they are released into the
environment, intentionally or unintentionally, the consortium said. "The
capacity of each synthetic organism to survive in the environment and
reproduce must be known before any such organisms leave the laboratory. …
Once released into the environment, these organisms may be impossible to
recall or eliminate," the group said its report.

To that end, the consortium wants governments to require that premarket
environmental impact assessments are conducted for each distinct synthetic
organism and each product derived from them.

Among other proposals, the coalition also said it wants a prohibition on
the use of synthetic biology to change the human genetic makeup, human
genome, epigenome, or microbiome, because any such genetic alterations "are
too risky and fraught with ethical concerns."

Gregory Kaebnick, a scholar at the Hastings Center, a non-partisan
bioethics organization, told *GenomeWeb Daily News* today that the
coalition is "calling attention to an important set of issues."

However, Kaebnick said that the coalition has focused its recommendations
too much on "halting commercialization," and the report appears to have an
"anti-corporate" message. He also said that they failed to consider
potential dangers of research projects, such as the recent development of a
dangerous new strain of H5N1.

Kaebnick also took issue with the coalition's central contentions
concerning regulation.

"I don't think it's true that synthetic biology is developing with little
oversight or regulation. There is a fair amount of talk at the federal
level about it. … The question is: What are the gaps in the existing
regulations? How do we deal with a technology that is changing and evolving
very rapidly? How do we set up oversight mechanisms?"

The Obama Administration responded to JCVI's synthetic microbe by
immediately commissioning a report, released in 2010, which included a
number of recommendations<http://www.genomeweb.com/white-house-council-receives-synthetic-biology-report>
for
addressing safety, security, and ethical questions involved in synbio.

That report, from the Presidential Commission for the Study of Bioethical
Issues, advised a policy based in prudent vigilance that involves ways to
use government and private sector resources to oversee synthetic bio
research and business without stifling innovation.

As *GWDN* reported last month, the administration has been pursuing
implementation of some of those recommendations, although about half of
them have spurred little or no
actions<http://www.genomeweb.com/report-card-governments-synthetic-bio-initiatives-shows-mixed-results>
or
have been disregarded.

Kaebnick suggested that the coalition's focus on corporations and its
heightened concern about synthetic biology business, as opposed to genetic
engineering research, may have colored its report and "gotten in the way of
the message."

"People freak out a little bit when they see the words 'synthetic biology
or 'genetic engineering,' particularly when you tack the word 'extreme' in
front of it," Kaebnick said.


James Clement, J.D., LL.M.
CEO, Androcyte LLC
U.S. Cell:  407-929-2965
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